MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder

Conditions

• Post Traumatic Stress Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 3,4-methylenedioxymethamphetamine — DRUG
  Initial doses per Experimental Session include 68 mg or 100 mg MDMA (equivalent to 80 mg or 120 mg MDMA HCl), followed 1.5 to 2 hours later by a supplemental dose of 34 mg or 50 mg MDMA (equivalent to 40 mg or 60 mg MDMA HCl).
• d-amphetamine — DRUG
  Initial dose per experimental session will be 5 mg or 10 mg d-amphetamine, followed 1.5 to 2 hours later by supplemental dose of 2.5 mg or 5 mg d-amphetamine.
• Therapy — BEHAVIORAL
  Participants assigned to MDMA and d-amphetamine will undergo a therapeutic approach, which is detailed in the MDMA-Assisted Therapy Treatment Manual and administered by MAPS-trained therapists. In brief, this therapy is guided by the subject's own recollections of traumatic events. The subject and two therapists provide a comfortable and supportive environment and allow the subject to guide the discussion. Subjects are encouraged to experience and express fear, anger, and grief with less likelihood of feeling overwhelmed by these emotions. MDMA seems to engender internal awareness that even painful feelings that arise are an important part of the therapeutic process. In addition, feelings of empathy, love, and deep appreciation often emerge, along with a clearer perspective of the trauma as a past event, a more accurate perspective about its significance, and a heightened awareness of the support and safety that exists in the present.

Study Details

This randomized, double-blind, single-site phase II 2-arm study will investigate the safety and preliminary efficacy of MDMA-assisted therapy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in participants aged 18 years and older with PTSD of at least moderate severity.

Key Dates

Start date

Mar 1, 2025

Status verified

Mar 2025

Primary completion

Mar 31, 2026

Completion

Mar 31, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: MDMA-Assisted Therapy
  Participants will receive a flexible divided-dose of MDMA plus therapy at Experimental Sessions.
• Active Comparator: Low Dose D-Amphetamine Assisted Therapy
  Participants will receive a flexible divided dose plus therapy at Experimental Sessions.

Primary Outcome Measure

Compare changes in PTSD symptom severity in the MDMA vs active control group. [ Time Frame: Visit 17 (approximately 14 weeks after enrollment) ]

Central Contacts

• Stephanie L Taylor, PhD
  213-505-1140
  [email protected]
• Stephen Marder, MD
  [email protected]

Locations (2)

Find similar trials in Los Angeles, CA

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